The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).
Men and women aged 18 years or older at the time of signing informed consent.
Able and willing to sign the informed consent form (ICF).
Ability to comply with the trial protocol.
Histologically confirmed Marginal Zone Lymphoma (MZL) of Extranodal Marginal Zone Lymphoma (EMZL), Nodal Marginal Zone Lymphoma (NMZL) and Splenic Marginal Zone Lymphoma (SMZL) subtypes presenting with stage I-IV disease.
Threatened extranodal organ function, especially for extranodal MZL
Involvement of ≥3 nodal sites, each with diameter of ≥3 cm
Any nodal or extranodal tumor mass with a diameter of ≥5 cm
B symptoms (fever ≥38 degrees Celsius of unclear etiology, night sweats, weight loss >10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement.
Single group
Epcoritamab
Biological/VaccineEpcoritamab will be administered via subcutaneous (SC) injection using a step-up dosing schedule as follows: * Cycle 1, Day 1: 0.16 mg * Cycle 1, Day 8: 0.8 mg * Cycle 1, Day 15: 3 mg * Cycle 1, Day 22: 48 mg * Cycles 2 to 3, Days 1, 8, 15 and 22: 48 mg * Cycles 4 to 9, Days 1 and 15: 48 mg * Cycles 10 to 12; Day 1: 48 mg
Complete Response (CR)
The proportion of participants achieving a best overall response of complete response (CR) after Cycle 12 of study therapy will be reported. Response will be assessed using modified Cheson criteria, if disease is not fluorodeoxyglucose (FDG)-avid in initial Screening; or by revised Lugano criteria if Screening FDG-positron emission tomography (PET)/ computed tomography (CT) demonstrated FDG avid disease. For Lugano criteria, CR will be defined by a Deauville score of ≤3.
Complete Response (CR)
The proportion of participants achieving a best overall response of complete response (CR) after Cycle 3 and Cycle 7 of study therapy will be reported. Response will be assessed using modified Cheson criteria, if disease is not fluorodeoxyglucose (FDG)-avid in initial Screening; or by revised Lugano criteria if Screening FDG-positron emission tomography (PET)/ computed tomography (CT) demonstrated FDG avid disease. For Lugano criteria, CR will be defined by a Deauville score of ≤3.
Partial Response (PR)
The proportion of participants achieving a best overall response of partial response (PR) after Cycle 12 of study therapy will be reported. Response will be assessed using modified Cheson criteria or revised Lugano criteria (based on FDG avidity), among evaluable participants.
Complete Response
The proportion of participants achieving a best overall response of complete response (CR) at 24 months after initiation of treatment will be reported. Response will be assessed using modified Cheson criteria or revised Lugano criteria (based on FDG avidity), among evaluable participants.
Overall Response Rate (ORR)
The proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) after Cycles 3, Cycle 7, and Cycle 12 of study therapy will be reported. Response will be assessed per Cheson or revised Lugano criteria (based on FDG avidity) modified for marginal zone lymphoma (MZL), among evaluable participants.
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Izidore Lossos, MD
Lead sponsor
University of Miami
Sponsor institution
Genmab
Collaborator
AbbVie
Collaborator
